The quality management software firm QT9 Software has outlined features of its QT9 ERP platform, an enterprise resource planning system designed for firms in regulated life sciences sectors, including medical devices, pharmaceuticals and biotechnology.
QT9 ERP is a pre-validated system that includes support for FDA 21 CFR Part 11 electronic records and approvals. According to the company, the platform is intended to reduce the need for custom validation work during implementation and to support audit preparation through built-in compliance features. QT9 Software says those compliance requirements can begin during product development and continue through design transfer and manufacturing scale-up.
The system provides real-time tracking of materials, inventory and production history, supporting end-to-end traceability across the supply chain. This includes visibility into raw materials, work-in-progress and finished goods, which can be used during audits, inspections or recalls, as well as during pilot builds and early production runs.
QT9 ERP consists of more than 17 integrated modules and can connect with QT9’s quality management system. The platform supports both cloud-based and on-premise deployments. Embedded workflows and automation tools are designed to reduce manual data entry and link information across functions such as demand planning, work orders and shop floor scheduling. QT9 Software says the system can also support change control and documentation continuity as products move from R&D into validated manufacturing processes.
The software includes portals for employees, customers and suppliers, allowing controlled access to documentation such as inspection records, batch documentation, and device files. Multi-site functionality allows organizations to view and manage operations across multiple facilities within a single system. QT9 Software says controlled access can help teams share current documentation during development, validation and tech transfer work.
Dashboards and analytics tools provide status reporting across operations, while reporting functions allow users to export ERP data for external analysis or business intelligence use. The system supports electronic batch records and medical device files, as well as multi-level bills of materials, routings, inspection data, job travelers and approval records. QT9 Software says this can help maintain version-controlled records as product specifications and processes evolve from development into production.
QT9 Software states that QT9 ERP is intended to support paperless manufacturing environments by centralizing production and compliance documentation and maintaining audit-ready records throughout the product lifecycle, including development, validation and commercial production.
